AxoGuard G52794
by Cook Biotech Incorporated 2 variants
AxoGuard G52794 (AGX610) is a Class II device made by Cook Biotech Incorporated, cleared under FDA 510(k) K162741 on 31 Oct 2016 (1 earlier submission) and listed in FDA GUDID since 3 Nov 2015 (UDI-DI 00827002527942), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k) | NumberK162741 | Date31 Oct 2016 | StatusActive |
| United States | GUDID listing | Number00827002527942 | Date3 Nov 2015 | StatusListed |
Official records
- AccessGUDID record 00827002527942
- FDA 510(k) database K162741
- FDA 510(k) database K031069
Across registries
- FDA 510(k) K162741 decided 31 Oct 2016 Active
- FDA GUDID UDI-DI 00827002527942 listed 3 Nov 2015 Listed
Timeline
- Cleared FDA 510(k) K031069
- Listed FDA GUDID 00827002527942
- Cleared FDA 510(k) K162741
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AxoGuard
- Generic name
- Nerve guide, animal-derived
- Model / Ref / Catalog
- G52794, AGX610
- Primary DI / UDI-DI
- 00827002527942
- FDA product code
- JXI
- GMDN term
- Nerve guide, animal-derived
- Device class
- Class II
- Regulation number
- 882.5275
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Similar devices in this category
Other devices filed under Nerve guide, animal-derived.